Friday, November 03, 2023
Some Scientists, Journals Pose 'Potential Threats to Vaccine Confidence', says CDC
Scientists and journals that conduct and publish certain research pose a problem for the federal government's vaccination campaigns that should be addressed, U.S. Centers for Disease Control and Prevention (CDC) officials wrote in newly reviewed emails.
Colin Bernatzky, a public health analyst with the CDC's Immunization Services Division, in one of the missives flagged a paper from scientists in the United States and several other countries that analyzed the effects of repeated COVID-19 vaccination.
Vladimir Uversky, a molecular medicine expert in Florida, and his co-authors noted that experiments have found multiple doses of the Pfizer and Moderna COVID-19 vaccines lead to higher levels of antibodies called IgG4, making the immune system more susceptible.
"COVID-19 epidemiological studies cited in our work plus the failure of HIV, Malaria, and Pertussis vaccines constitute irrefutable evidence demonstrating that an increase in IgG4 levels impairs immune responses," Alberto Rubio Casillas, one of the co-authors, told The Epoch Times.
The paper was published following peer-review by Vaccines.
Mr. Bernatzky took issue with the paper and The Epoch Times' coverage of it despite acknowledging he wasn't sure about its veracity.
"At the very least, it seems like there's some editorial recklessness going on, especially since the net result is that this research is being viewed as legitimate and is circulating widely. (And if the research is in fact legitimate, it should be on CDC's radar)," he wrote.
About a week later, on July 7, Mr. Bernatzky provided colleagues with more information on what he described as "potential threats to vaccine confidence posed by select scientific journals and publishers."
The paper from Mr. Uversky and Mr. Casillas "has been accumulating a massive amount of attention," Mr. Bernatzky said, with a high attention score that was "undoubtedly driven" mostly by The Epoch Times article.
"Unfortunately, the Uversky paper is part of a wider pattern of academic journals conferring legitimacy to anti-vaccine claims through their willingness to publish low-quality work (e.g., reviews with lots of conjecture rather than original research) as well as their apparant reluctance to issue retractions or disclaimers when these issues are called to their attention," he added.
The CDC official noted that the paper was cited by Massachusetts Institute of Technology research scientist Stephanie Seneff and her co-authors in response to criticism of a paper they wrote that outlined concerns with how the vaccines impact the immune system.
The author list of that paper "turns out to be ... a squad of vaccine skeptics that includes Peter McCullough," Mr. Bernatzky said, referring to a U.S.-based cardiologist that has expressed concerns about the safety of the COVID-19 vaccines, "with a track record for promoting ideas about autism, vaccines, Roundup, etc."
Mr. Bernatzky suggested the "systemic issues" with certain scientists and publishers should be addressed, describing the matter as "complicated." He pointed out that a new paper by Dr. McCullough was published as a preprint by The Lancet but quickly removed, spurring criticism.
The email was circulated widely within the CDC, according to other missives obtained by The Epoch Times, with officials focusing on the paper by Mr. Uversky and Mr. Casillas and its conclusions.
"Apparently it's gone viral," Sarah Meyer, another CDC official, said while sharing the email with a colleague. She said she also sent the concerns to the CDC's Coronavirus and Other Respiratory Viruses Division.
Karen Broder, the colleague, forwarded the email to Drs. Tom Shimabukuro and John Su, two top CDC vaccine safety officials.
None of the CDC officials, including Mr. Bernatzky, responded to inquiries. A CDC spokesman declined to comment.
Mr. Bernatzky has sociology degrees and has written that the "anti-vaccine movement is arguably one of the more concerning social movements to have surfaced during the first two decades of the current century." He has also alleged that support for former President Donald Trump is linked to "hate material."
The CDC regularly publishes and promotes papers that have not been peer-reviewed in its quasi-journal, Morbidity and Mortality Weekly Report. In the full set of emails, which were obtained through the Freedom of Information Act, officials on multiple occasions used those papers to craft guidance to the public on COVID-19 vaccine safety.+
The journals Vaccines and Food and Chemical Toxicology, which the CDC singled out for criticism, did not return requests for comment.
Mr. Casillas, a doctor at Autlan Regional Hospital in Mexico, told The Epoch Times in an email that the CDC never contacted him and said the paper he helped put together "must be read and interpreted for what it is: a hypothesis."
"In our work, we developed a series of hypotheses about the possible consequences of a high concentration of IgG4 antibodies induced by repeated mRNA vaccination. It is important that health experts and the general public understand that we never categorically stated that, for example, such antibodies induce cancer. If you read our work, you will notice that throughout the article we used words that denote the nature of a hypothesis," he said.
Mr. Casillas said the CDC's criticism was unwarranted.
"Each of our proposals is based on previous research. They must be evaluated experimentally to be confirmed or refuted. It is the only way science can advance to obtain safer vaccines. We are aware that we may be wrong, but we do not accept that our work is criticized based solely on opinions," he wrote.
Ms. Seneff said that the paper from Mr. Casillas and his co-authors was "a very thorough review that reveals the complexity in the immune system's reaction to antigenic exposures, and examines the potential adverse consequences of the experimentally observed high levels of IgG4 antibodies induced by repeated vaccination with the SARS-CoV-2 mRNA vaccines."
She said that her view on the research into the IgG4 antibodies is that the antibodies are not protective and block other, protective antibodies. She also sees the elevated levels of IgG4 antibodies as linked to serious problems, including severe autoimmune disease.
"This paper is seminal, and it is not surprising that it has gone viral, due to its deep analysis of the significance of elevated IgG4 following mRNA booster shots," Ms. Seneff told The Epoch Times in an email. "I doubt that the mainstream position that these vaccines are safe and effective can survive much longer, even as they continue with aggressive efforts to retract the comprehensive review papers that reveal the true colors of these experimental therapies."
Dr. McCullough told The Epoch Times via email that the CDC and other health agencies would be better served holding open meetings "instead of emailing gossip between each other."
If they held the meetings, he said, officials "can hear directly from the nation's experts who learned how to treat acute ambulatory COVID-19 and who are now handling the tsunami of patients with COVID-19 vaccine injuries, disabilities, and deaths."
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Lack of Informed Consent and Disabling Stroke after Pfizer mRNA Vaccination
It has been difficult for COVID-19 vaccinated Americans to process what has happened to their bodies. Public testimony by mRNA vaccine victims has been a relatable way of try to understand what has happened to our citizenry with a mass, indiscriminate COVID-19 vaccination campaign that failed on the informed consent process as reports of side effects poured into vaccine data systems.
On October 20, 2023, The Novel Coronavirus Southwestern Intergovernmental Committee convened a hearing to review new developments on the COVID-19 vaccine safety debacle and broader issues of informed consent which was highlighted by these words from Committee Chair, Senator Janae Shamp, who is a registered nurse. Be sure to listen to her opening remarks and play to through to heartwrenching story of media executive Ms Calli Varner.
Calli Varner, age 37, with Pfizer mRNA stroke with left face and body paralyzed. She was airlifted to a tertiary center and treated with thrombolytics in 2021
The 37 year-old woman gave her vignette of suffering a stroke after Pfizer, mRNA COVID-19 vaccination. This stroke was so serious she had to be airlifted to a tertiary center and receive thrombolytics (clot-busting drugs). Because the mRNA installed the genetic code for the Wuhan Spike protein, she then had the development of premature menopause, auto-immunity, and a rapidly growing thyroid nodule.
I told the committee and the audience in attendance, this could not have all been attributed to 15 years of oral contraceptive use as Calli’s doctors claimed. I cited medical literature that clearly demonstrate the COVID-19 vaccines cause stroke and doctors are willfully blind to the damaging effects of the vaccines.
LTC Dr. Pete Chambers stated that disabling vaccine injuries are happening to our soldiers. He implored people to have courage, speak out, and “stand in the gap” to warn others. That will be the only way to prevent more causalities.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Thursday, November 02, 2023
European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine
Pfizer did not highlight a DNA sequence in its COVID-19 vaccine, a European regulator has confirmed.
"While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorization application for Comirnaty, the applicant did not specifically highlight the SV40 sequence," the European Medicines Agency (EMA) told The Epoch Times in an email.
The email came after Health Canada told The Epoch Times it expects sponsors to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer but that Pfizer did not.
Pfizer and its partner, BioNTech, have not responded to requests for comment.
Pfizer did not highlight the inclusion of the enhancer in its vaccine because "it was considered to be a non-functional part of the plasmid," EMA said. "They have since clarified this information in response to questions raised by EMA."
The EMA said parts of the SV40 sequence are "commonly present in plasmids used for manufacturing of biological active substances," but neither authorities nor Pfizer have been able to say why the sequence was made part of the Pfizer shot.
Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, told The Epoch Times "there is no reason" to include the sequence. He has urged U.S. regulators to recall the vaccine, but the regulators have declined.
Contested Claims
According to the EMA, the DNA sequences, including the SV40 sequence, are "broken down and removed" during the manufacturing process. "Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled," the EMA claimed.
The agency did not provide any evidence to support the claim.
"The best independent estimates are 100-200B fragments of the plasmid exist in each dose," Kevin McKernan a microbiologist who first identified the sequence in the vaccine, told The Epoch Times in an email. "The EMA has offered no scientific evidence to make such a claim other than 'Trust our non-peer reviewed heavily redacted failure in transparency.'"
An EMA spokesperson said earlier this year that there was "no evidence to indicate the presence of SV40 ... in the formulation of COVID-19 vaccines."
The EMA is now acknowledging that statement was not correct.
But the regulator said it "has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals."
It also said, "we have not seen any reliable evidence of residual DNA exceeding approved/safe levels for" the Pfizer vaccine.
Dr. Malone said that the standards they're citing were not designed for the Pfizer and Moderna vaccines, which use modified messenger ribonucleic acid (RNA) technology.
"The safe threshold in the presence of these delivery complexes is something that must be established experimentally by performing genotoxicity studies," Dr. Malone said. "To say that just because we haven't detected it, or it's below the level that we normally accept with, say a flu vaccine, is completely irrelevant."
Fragments Act as Mutagens?
Some scientists say they're concerned because the DNA fragments could act as mutagens, or change the DNA sequence in a gene, even when taking into account how the SV40 sequence in the vaccine is not the cancer-causing large T antigen.
"The thing is that the smaller pieces actually could be very significant," David Wiseman, a former Johnson & Johnson scientist, told The Epoch Times. "They could actually get into your genome, potentially."
Mr. Wiseman was part of a team that recently detected levels of residual DNA in Pfizer's vaccine, as well as in Moderna's vaccine.
Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases, and Immunology at the Faculty of Medicine at Laval University, told The Epoch Times that the danger of the SV40 enhancer being present in the vaccine is its possible integration into a cell's DNA genome.
"All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person," he said.
Responding to those concerns, the EMA said that "there is no scientific evidence that any of these SV40 fragments can act as insertional mutagens."
Dr. Malone said that was not true.
"Short DNA fragments and oligonucleotides are specifically used in modern biomedical research to experimentally alter the genomes of cells and embryos," he wrote in an email. "Such DNA fragments are well known to those skilled in the art to be useful for altering genomic information and genome integrity via both recombination and insertional mutagenesis."
Mr. McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, noted that scientists have found that SV40 sequences are optimal for gene therapy and that one paper described a rate of insertional mutagenesis with transfection being as high as 7 percent of the modified cells.
"Given the EMA waived all genotoxicity studies, their statement is nothing more than complicit wishful thinking," Mr. McKernan said.
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FDA Medicare SafeRx Study—Elevated Risks of Stroke Detected from conjuction of COVID-19 & Influenza Vaccines
Thanks to funding from the SafeRx Project, a joint initiative of the Centers for Medicare & Medicaid Services and the Food and Drug Administration (FDA), a group of authors employed at the FDA (the Agency) and a government contractor called Acumen LLC recently completed a self-control case series (SCCS) study tapping into a vast Medicare database (SafeRx). The mission is to investigate any risks of ischemic stroke associated with the COVID-19 vaccine.
This study was prompted by a concern expressed January 2023, by both the FDA itself and the Centers for Disease Control and Prevention (CDC) for an increased risk of ischemic strokes in adults aged 65 years and up after receiving the COVID-19 vaccine (bivalent targeting BA.4/BA.5); plus, the prospect of such a possibility involving the COVID-19 vaccine and concomitant high-dose/adjuvanted influenza vaccine.
This presented analysis tapped into and analyzed data from the Medicare fee-for-service (FFS) population aged ≥65 years. The agency-sponsored study team sought to estimate the risk of incident stroke following COVID-19 bivalent vaccines among Medicare beneficiaries. The study team evaluated stroke risk among age groups, following influenza vaccines, and following concomitant influenza and COVID-19 bivalent vaccine administration from August 31 to November 6, 2022.
While the primary analysis found no elevated risk, specific subgroup analyses identified elevated risk including A) increased risk for persons age 85 years and up for both non-hemorrhagic stroke (NHS)—another term for ischemic stroke, and transient ischemic attack (TIA) with the Pfizer bivalent COVID-19 bivalent vaccine as well as B) an increased risk for both NHS and TIA for those Medicare beneficiaries who received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine (NHS with Pfizer and TIA Moderna).
Finally, C) the authors found upon completion of secondary analysis a small increased risk of NHS linked to the high-dose or adjuvanted influenza vaccines. While the FDA-sponsored investigation detected such elevated levels of risk, the authors remain steadfast as to the substantial benefits of vaccination, mindful of the risks associated with viral infection leading to an overall reaffirmation as to the safety of these medical products.
What’s the Concern?
The study authors herein address endpoints including the linking of the COVID-19 vaccine as well as influenza vaccine and ischemic stroke. Specifically identified are both the non-hemorrhagic stroke (NHS) and the transient ischemic attack (TIA).
An NHS or ischemic stroke is a type of stroke that occurs when blood flow to a part of the brain is blocked. This blockage can be caused by a blood clot or atherosclerosis, which is the narrowing and hardening of the arteries. Importantly, Ischemic or NHS are the most common type of stroke, accounting for over 80%.
A TIA is often called a “mini-stroke” and represents a medical condition that mimics the symptoms of a stroke but is temporary and does not cause permanent brain damage. These occur due to a brief interruption of blood flow to the brain.
A Robust Study
Led by agency veterans including Stephen Johnson, Ph.D., Director, Office of Biostatistics and Epidemiology, and Richard Forshee, Ph.D. Deputy Director Office of Biostatistics and Pharmacovigilance, the study team included vaccinated individuals’ data only, leaving them not subject to bias due to underreporting of vaccination status in the claims data. Also, Johnson, Forshee and colleagues claim they mitigated any misclassification bias by conducting medical record reviews of the claims-based NHS definition.
The study authors here report on numerous study strengths, such as a robust, large, representative Medicare database, with minimal beneficiary attrition, ensuring highly generalizable findings to the elderly U.S. population.
They also point to the ability of this self-controlled study design to adjust for time-invariant confounders such as health conditions, socio-economic status, and health-seeking behavior. Such factors can inherently bias a study, drawing from between-individual comparisons.
Results Summary
As reported in the preprint server medRxiv, a primary analysis failed to detect elevated stroke risk post-COVID-19 bivalent vaccination.
However, while slicing and dicing the data, including analyses involving subgroups, the study authors report that the cohort of ≥85 year associated with a risk of non-hemorrhagic stroke “(NHS) (Incident Rate Ratio (IRR)=1.36, 95% CI 1.09 – 1.69 [1-21 days]) and NHS/ transient ischemic attack (TIA) (IRR=1.28, 95% CI 1.08 – 1.52 [1-21 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5.”
When analyzing the data associated with the Medicare beneficiaries “that received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine, an increased risk was observed for NHS (IRR=1.20, 95% CI 1.01 – 1.42 [22-42 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5 and for TIA (IRR=1.35, 95% CI 1.06 – 1.74 [1-21 days]) with mRNA-1273.222.”
The authors summarized that once completing their secondary analyses, they detected “a small increased risk of NHS following high-dose or adjuvanted influenza vaccines (IRR=1.09, 95% CI 1.02 – 1.17 [22-42 days]).”
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, November 01, 2023
Disastrous Covid vaccination campaign in Poland
Poland’s National Audit Office known as “NIK” has identified a substantial surplus of COVID -19 vaccines due to lack of demand. The nation had contracted for a full vaccination rate multiple times over, yet the national office reports vaccination rate decline. Consequently, 13.1 million doses were allowed to expire and then exposed by the end of 2022, representing PLN 1 billion (US$237.7 million). In total, Poland spent 13.9 billion PLN (US$3.3 billion) for this nation of only 37.7 million people. TrialSite reminds that this was one of the few media to cover Poland’s attempt to renegotiate the COVID-19 vaccine contract with Pfizer due to the impact of the Russian invasion of Ukraine. Pfizer refused to budge. What follows is what in reality is a damning report from the NIK as to what appears to be an unfolding scandal in the aftermath of the COVID-19 response.
The NIK reports the effort to sell, transfer or donate the COVID-19 vaccines to mitigate the effects of the excess. By 31 December 2022, the Governmental Strategic Reserves Agency (RARS) provided to other countries over PLN 27.6 million vaccine doses with an estimated value of PLN 1.4 billion or (US$333.3 million).
A Great & Deadly ‘Health Debt’ Caused by COVID-19 Response
The NIK has gone on record that the COVID-19 response caused significant disruptions in the healthcare provision. Above all, a great part of the healthcare system resources was “relocated” to control the epidemic. That resulted in shrinking access to treatment for a broad group of patients, diagnosed with diseases other than COVID-19. Hence, the so-called health debt was growing (that was a situation where the failure to provide a medical service may lead to a disease development or its worsening).
Excess Deaths during the Pandemic—Despite the Vaccine
In 2020-2021, an increased number of deaths was reported, as compared with the average of 2015?2019. In 2020, there were over 85 thousand more of them, including about 56.5 thousand deaths for reasons other than COVID-19. And in the first half of 2021, excess deaths against the number of deaths reported a year before totaled nearly 61 thousand. But what about the COVID-19 mass vaccination response?
In fact, the COVID-19 universal vaccination countermeasure was supposed to help prevent those negative phenomena. The vaccination did not succeed despite many claims that the vaccines saved millions of lives. TrialSite has reviewed dozens of observational studies suggesting that the vaccines have reduced morbidity and mortality but the nature of these studies are such that this does not prove causation.
NIK points out in line with the assumptions the vaccines should have ensured a “return to normal.” While also serving to “unblock” the healthcare system, particularly for patients with diseases other than COVID-19. As NIK declares in a recent media entry a direct objective in the COVID-19 National Vaccination System was:
to reduce the number of deaths and complications caused by the SARS-CoV-2, particularly in elderly persons,
to reduce the population “health debt” growth.
In 2021-2023, NIK conducted a range of ad hoc audits to establish if the objectives of the COVID-10 National Vaccination Programme were achieved and how. NIK carried out five audits to look into the Programme execution which cost about PLN 17 billion (US$4.05 billion).
The NIK audit revealed that:
The Minister of Health improperly estimated needs related to the purchase of an adequate number of COVID-19 vaccine doses (meaning that the Ministry ordered more doses than they needed to, which of course meant more taxpayer dollars to the pharmaceutical companies).
Poland did not have to enter into agreements - questioned by NIK - to purchase COVID-19 vaccines. The Minister of Health did not use that right.
Estimating demand
It needs to be underlined that no documents were presented showing how the number of vaccine doses, needed to satisfy the demand of Polish citizens, were estimated. There was no basis, no rationalization used to justify the large spend.
From May 2021, subsequent vaccine doses were contracted for, although Poland was bound with contracts enabling the vaccination of the entire population several times (109 million doses were contracted for at the end of April 2021).
Even assuming that every adult person in Poland, i.e., about 31 million individuals, received the third vaccine dose, the demand would be at the level of 93 million doses, i.e., lower than the number of doses contracted for before May 2021.
What did the Health Ministry Know?
Interestingly, what did the Polish Ministry of Health know about the COVID-19 pandemic that informed them to estimate such demand?
NIK reports that the Minister of Health formulated a thesis that prior to the execution of agreements indicated as improper, there were signals that vaccine boosters every 6 months are necessary to maintain the immunological response at an adequately high level. The thesis is not only unconfirmed by the evidence gathered in the audit but also it does not reflect the opinions of specialized EU institutions taking efforts to control the COVID-19 epidemic.
On 31 May 2021, the Minister of Health addressed the EU Health Commissioner concerning the vaccines purchased, pointing to the hazard of huge vaccine surplus in Europe and the need for coordinated cooperation to start talks with individual manufacturers to reduce the volumes of vaccine orders.
NIK emphasizes that the Health Ministry could have been culpable in questionably intentioned pursuits.
“It needs to be stressed that the Minister stated that the epidemiological situation is about to stabilise and pointed to the “hazard” of significant surpluses of the COVID-19 vaccines, only 11 days after signing the third agreement with Pfizer/BioNTech. It points to complete inconsistency of the Minister’s actions. According to NIK those measures were unreliable and wasteful.”
Poland’s COVID-19 Vax Contracts
As reported by the NIK, the Republic of Poland acquired the COVID-19 vaccines as part of the Agreement on the joint mechanism for the COVID-19 vaccine purchase.
The Agreement authorized the European Commission to negotiate and conclude vaccine purchase contracts, on behalf of the EU Member States. Remember, TrialSite reported on how at least part of the EC negotiation was done via private personal text between Pfizer’s CEO Albert Bourla and Commission President Ursula von der Leyen. The situation is so egregious that even the New York Times has sued the EC to get to the bottom of this possible scandal.
NIK reports that the EC as an entity took responsibility for the contracts’ content, including the principles of sharing vaccines among the EU Member States, the pool of vaccines covered by the contract, their prices and delivery dates.
The EC notified the EU member states of the former’s intention to sign the deal, and the reality that the latter had no rights to modify. NIK does inform that member states were notified that they did have the option to withdraw from the vaccine purchase contract. It was a take it or leave it deal.
NIK informs the world now that in the vaccine purchasing process two types of contracts were used: 1) contracts defining the right to purchase vaccine doses and 2) contracts defining the obligation to purchase them.
First, NIK notes that participating EU Member States were not obliged to sign that contract. With the second contractual model, the EC was obliged to inform the EU Member States about the intention to sign the contract with an obligation to purchase the vaccine doses, also defining its signing conditions. Again, Member States had not input.
NIK cites the problems with the contractual scheme as devised:
“All the contracts negatively evaluated by NIK were contracts defining the obligation to purchase COVID-19 vaccines. The states that did not agree to sign that contract or its conditions had 5 days to withdraw from the contract or declare a number of vaccines other than set out in the contract (the so-called “opt-out clause”).
NIK points out in their media entry “The opt-out clause required consent of partner states, in cooperation with the EC, to accept extra doses or to give away appurtenant doses.”
Outrageous: 117.6K Hazardous COVID-19 Vax Doses Administered to Polish Population
TrialSite also learned about this scandal in the recent NIK media piece, under the section “Supervision of the Chief Pharmaceutical Inspectorate (GIF) over the COVID-19 National Vaccination Programme.”
NIK added in its report the state’s negative evaluation supervision exercised by the Chief Pharmaceutical Inspector over the vaccine storage and distribution. The body responsible for pharmaceutical safety of the state, obliged with “special supervision”, did not know in which warehouses the vaccines were stored. This NIK reports, “The relevant information was taken from the media,” meaning the nation state had no control over the pharmaceutical product within its borders.
The Polish government found defects, yet as the government itself via the NIK reports, “GIF failed to take efforts to withdraw part of vaccines, in which some quality defects were found, also the ones posing a threat to health and life. In consequence, 117.6 thousand hazardous vaccine doses were administered to patients.”
Distribution and storage of vaccines
According to the NIK audits, 17 pharmaceutical warehouses were involved in the process of the COVID-19 vaccine distribution and storage. In the audited period, GIF carried out only two inspections in one of pharmaceutical warehouses taking part in the COVID-19 vaccine distribution.
“A lot of critical irregularities were identified, e.g., the vaccine storage conditions in special rooms or the vaccine transport from the Governmental Strategic Reserves Agency (RARS) were not registered. Also, the product safety was not provided during vaccine storage in that warehouse.”
NIK reports an alternative inspection targeting the same supply pointed to a scandalous takeaway: the “distribution process does not guarantee the safety of vaccines in terms of their quality maintenance.”
While European GIF inspectors were in fact, cognizant of the discovered irregularities adversely impacting COVID-19 vaccine safety and effectiveness, they carried out no inspections in the remaining 16 warehouses.
Consequently, Poland’s national auditor points out how the Minister of Health was culpable in an unfolding scheme:
“The Minister of Health had a significant, adverse impact on the effectiveness of actions taken by GIF. He made the following statement which was contrary to the applicable law:
the distribution of COVID-19 vaccines is not the trade in medicinal products, in the light of the Pharmaceutical Law Act, and hence,
the trade in vaccines may not be monitored via the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL).”
Poland’s Minister of Health essentially blocked and tackled on behalf of what appears to be some kind of cabal consisting of EC bureaucrats, industry and perhaps other high placed persons. After all, thanks to the Minister’s efforts “pharmaceutical warehouses were freed from the obligation to report vaccine stock availability on a daily basis. Hence, GIF could not monitor the trade in those vaccines. The Inspectorate drew its knowledge about the COVID-19 vaccine warehouses from the media.” This unfolding scenario could only be considered an utter and complete scandal.
Risking Patient Safety
TrialSite reminds all that national health authorities exist to ensure the safety and welfare of the population, not to further endanger them.
Yet Poland’s own auditors report that “The decision of the Minister of Health not to use the monitoring system also had a negative impact on the safety of patients.”
The NIK informs the world:
“In two cases, GIF did not decide to withdraw from the market a series of vaccines, although the Inspectorate was aware of their quality defects. GIF could not withdraw the vaccines, because their distribution was not subject to the Pharmaceutical Law Act – in line with the interpretation of the Minister of Health, and so GIF had no legal grounds to withdraw them from the market. Besides, the Inspectorate did not know in which warehouses the defective vaccines were found.”
Vaccine quality defects
GIF received eight reports of actual or alleged quality defects of the COVID-19 vaccines, of which two were of significant importance, reports the NIK media entry.
Additional Notes
On 23 April 2021, the Chief Pharmaceutical Inspectorate received information in the Rapid Alert system from the European Medicines Agency, about a possible quality defect in one of the COVID-19 vaccine series, already used in Polish patients. The report dealt with the suspicion of a 2nd class defect, that is the one that could cause an illness or improper effects. GIF failed to issue a decision to withhold or withdraw that vaccine series from the market.
Meanwhile, in April 2022 the Federal Agency for Medicinal and Health Products in Belgium informed GIF about withdrawing that series from the market. Having received the report, GIF provided the relevant information to RARS, requesting the Agency to take action to identify distribution channels and inform recipients about the situation. The efforts were pointless, though, because the entire vaccine series was already administered to patients
the quality defect of the vaccine series was reported on 7 April 2022 by the Spanish Agency of Medicines and Medical Products (AEMPS).
In the second case The vaccine quality defect could pose a threat to patients’ health and life (1st class defect), which obliged GIF to withdraw the defective product from the market.
Summary of Breaches Risking Patient Health
Summarizing this scandal, NIK reports that “In both cases, GIF not only failed to withdraw the vaccine series from the market but also did not know where they can be found.”
Having received the report, information was passed on to RARS with a request to identify distribution channels and notify recipients about the situation. The Chief Pharmaceutical Inspector explained that in the light of the Minister of Health’s interpretation, the decision to withdraw the vaccine could not be issued for the product that is not in the market. That information was also provided to RARS.
The government's vaccination commissioner
The Chancellery of the Prime Minister and the Government Commissioner for the National Vaccination Programme dealt mainly with conducting campaigns encouraging Polish people to vaccinate. Over PLN 155 million (US$36.9 million) was spent in pursuit of that aim.
In parallel, no definitions were established to determine the effects of this initiative. How could they know what success is?
While the Commissioner according to the NIK had an obligation to analyze the relevant activated legislation as well as existing solutions as they relate to prophylactic vaccinations, the office failed to do so whatsoever. The Commissioner simply deferred to analyses promulgated by the Minister of Health. This is truly problematic.
The Commissioner was also obliged to prepare proposals of new legal solutions and initiatives in terms of the COVID-10 National Vaccination Programme.
“In view of the above, according to NIK, it was unjustified to appoint a vaccination commissioner, whose tasks could be discharged by the existing state bodies.”
In performing his tasks, particularly in drafting changes to resolutions on the National Vaccination Programme, the vaccination commissioner drew on the information and knowledge of the Government Analysis Centre, the Ministry of Health, the National Health Fund, the e-Health Centre, the Government Security Centre or the Chief Sanitary Inspector.
After the vaccination commissioner’s office was lifted, the Programme supervision was entrusted to the Minister of Health, meaning a complete takeover, clearing the pathway for the exact COVID-19 countermeasure execution NIK founds so many troubles with.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, October 31, 2023
Covid Inquiry An Embarrassment To The English Legal System
Its exorbitant costs already cannot be justified, and there is only worse to come. It should be abandoned
Of all the crass misappropriations of scientific principles during the pandemic, none did more harm than the corruption of the ‘precautionary principle’.
The notion that an action or an intervention is justified only once one is clear that the benefits exceed the harms and that, as one sociologist put it, “you have looked very hard for the harms”.1
That principle came to be almost wholly inverted in the context of the pandemic: an intervention seemingly could be justified on the ‘precautionary’ basis that if it might have any beneficial effect in slowing the course of the pandemic, it would be worthwhile.
This justified indiscriminate measures ranging from universal masking, mass testing (including of young children), 14 day isolated quarantines, and even lockdown itself, for entire healthy populations on the basis that even though the evidence base was often weak or non-existent, the intervention just might achieve something, and opened the door to a slew of harms impacting almost all cohorts of the British population.
It was to be hoped that a core task for the Covid Inquiry in this key Module 2 would have been a dispassionate objective assessment of whether the costs (financial costs, direct harms, probable indirect harms, risk of unquantified future harms) of the Government’s population-wide interventions outweighed possible benefits.
So, it was deeply disappointing last week to see not only key witnesses but the Inquiry Chair herself repeat the same dangerous misconception of the precautionary principle.
In one of the most jaw-dropping interjections of the Inquiry to date, Baroness Hallett appears to have revealed a prejudgment that if masking people could have had even the slightest of benefits, and seemingly without even contemplating that risks and known harms might need to be weighed too, it should have been imposed.
She pressed Sir Peter Horby, an esteemed epidemiologist at Oxford University, who had indicated that he believed universal masking was not a straightforward decision:
“I’m sorry, I’m not following, Sir Peter. If there’s a possible benefit, what’s the downside?”
Coming from the independent Chair of a public inquiry, this is an astonishing comment.
It betrays a presumption, or at the very least a predisposition, to accept that it was better to act than not to act — the reverse of the precautionary principle. When a comment such as this, from the Chair of the Inquiry, goes unchallenged, it risks anchoring the entire frame of reference for the Inquiry’s interrogation of this critical topic.
In our view it was a surprising and serious error of judgment for an experienced Court of Appeal judge.
What made Baroness Hallett feel this to be an appropriate thing to think, let alone say out loud? We suggest the issue may be that the Chair and the official counsel to the Inquiry appear already to have the storyline of the pandemic wrapped up.
The Inquiry’s counsel has been at pains to paint a picture of the country facing an almost existential threat from the virus. From the outset, counsel has framed their questioning on the basis that it was indisputable a “highly dangerous fatal viral outbreak was surely coming”,2 and “… by February this viral, severe pandemic, this viral pathogenic outbreak is coming, and it can’t be stopped…”.3
Even hardened lawyers and epidemiologists, it has seemed, were bunkering down because “the virus was coming, it was a fatal pathogenic disease …”.
And, with the precautionary principle inverted in the collective mind of this Inquiry, almost anything the Government then did against that backdrop was justified.
With Preference…
Worse still, it is now starkly evident that the witnesses whose opinions and perspectives support that proposition are being overtly praised and pedestaled; while those whose opinions and perspectives might cast doubt are treated with prejudice and hostility.
For those witnesses who were part of the ‘home team’ — Government-appointed advisors, and those who have already publicly ascribed to the Inquiry’s apparently favoured storyline — impeccable credentials and impartiality have been assumed.
Sir Jeremy Farrar, for example, former director of the Wellcome Trust, member of SAGE and currently chief scientist at the WHO gave oral evidence to the Inquiry in June. One can almost picture counsel for the Inquiry scattering rose petals as he sums up Farrar’s illustrious credentials:
“You trained, I believe, in medicine, with postgraduate training in London, Chichester, Edinburgh, Melbourne, Oxford and San Francisco.
You have a DPhil PhD from the University of Oxford. You were a director of the Oxford University Clinical Research Institute at the Hospital for Tropical Diseases in Ho Chi Minh City in Vietnam from 1996 to 2013.
From 2013 you were Director of the Wellcome Trust, and from May 2023 have you been the Chief Scientist at the World Health Organisation? Have you throughout your professional career served as a chair on a multitude of advisory bodies, for governments and global organisations?
Have you received a plethora of honours from a number of governments, institutes and entities?”4
Farrar is then treated to counsel’s softest underarm bowls and allowed to give unchallenged testimony in favour of an intervention-heavy approach to pandemic management:
“when you have the countermeasures you’re talking about, diagnostic tests, treatment and vaccines, together they create a Swiss cheese model of what our public health is”.5
Professor Neil Master of Disaster Ferguson of Imperial College London, and chief architect of the dramatic scientific modelling on which the global lockdown response was predicated was warmly welcomed to the witness box by counsel last week “as a world leading specialist in this field”, and was later thanked profusely for his hard work by Baroness Hallett:
“… thank you very much for all the work that you did during the pandemic”.6
Gushing perhaps, but nothing compared to the farewell given to SAGE modeller Professor John Edmunds who had been affirmed up front by counsel as, “a de facto expert in epidemiology”, and one of “a number of brilliant scientists and advisers who assisted the government and the country in the remarkable way that you did”.7
At the end of his evidence, Baroness Hallett delivered the eulogy:
“Thank you very much indeed. If I may say so, Professor, I think you were unduly harsh on yourself this morning.
You had a job, and you described it yourself, your job was to provide expert advice to the policy and decision-makers, and if the system is working properly that advice is relayed to them, then they consider advice coming from other quarters about economics and social consequences and the like.
I’m not sure you could have done more than you did, consistent with your role at the time, but you obviously did as much as you felt was appropriate. So I’m really grateful to you, I’m sure we all are.”8
This is a far departure from the rigorous testing of credentials and potential conflicts that one could expect as an expert witness in any court proceedings under the studious impartiality of the presiding judge.
It is certainly far short of what the public should rightly expect for an exercise set to spend over £55m on lawyers alone.9
None of these witnesses were asked whether their senior positions within organisations that rely on very valuable relationships with global pharmaceutical groups and private pharma-focussed organisations could have had any bearing on their advice at the time or their evidence to the Inquiry now.
Farrar was director of the Wellcome Trust throughout the pandemic. The Wellcome Trust is one of the institutions behind CEPI, a global vaccine development fund created in 2015 which partners with vaccine manufacturers, including Moderna.
During the pandemic Farrar frequently and vocally promoted his view that vaccines would be the means for us to exit the pandemic. He is plainly someone whose professional success and credibility has become indelibly attached to the pharmaceutical industry and in particular the use of pharmaceutical interventions in public health, yet counsel and the Inquiry Chair seemed uninterested in that colouring of Farrar’s evidence.
Likewise, Ferguson, of Imperial College London was not asked a single question about potential conflicts or risk of bias.
Again the Inquiry seemed unaware, or at least uninterested, that a month after Ferguson’s seismic March 2020 paper had concluded that “…epidemic suppression is the only viable strategy at the current time” and that “the major challenge of suppression is that this type of intensive intervention package – or something equivalently effective at reducing transmission – will need to be maintained until a vaccine becomes available…”, it was reported that Imperial College had received £22.5 million in funding from the UK Government for vaccine research and development; and that in that same year, 2020, Imperial received at least US$108 million in funding from the Bill and Melinda Gates Foundation.10
BMGF is a private philanthropic organisation which has been open about its ideological commitment to vaccine-based solutions for global health issues and which itself has very significant financial ties to the pharmaceutical industry.
…And With Prejudice
For witnesses such as Professor Carl Heneghan, Professor of Evidence-Based Medicine at Oxford University, but not a member of SAGE, and (unhelpfully for the Inquiry) not an enthusiastic supporter of lockdowns, the Inquiry appeared to have made somewhat less glowing presumptions:
“You are a professor of evidence-based medicine at Oxford University. Could you explain what that discipline entails?”. Heneghan’s explanation was swiftly followed with a presumptive conclusion as to the strength of his credentials:
“as you know, because I think you have been following the Inquiry, we have heard this week from a series of academics who have spent, in the main, their professional careers researching, analysing the spread of infectious diseases, developing models, to analyse how such diseases are spread and how they can be controlled, and considering large-scale public health issues relating to pandemic preparedness and so on.
You don’t have a comparable type of expertise in this area, do you?”.11
Not satisfied with having attempted his own disparagement of the man, counsel took the opportunity while having Heneghan in the witness box to ask for his perspective on two ‘home team’ scientists having described him in a private discussion as a “fuckwit” (Dame Angela McLean and Professor Edmunds) — to what ends, other than to rattle, rile or embarrass, was not clear.
It was the cheapest shot of the Inquiry so far.
During Heneghan’s evidence session, and having seemingly felt entirely comfortable to rely on the expert opinions of Farrar, Ferguson, Edmunds et al — the ‘good guy’ home team scientists —Baroness Hallett gives short shrift to the notion that Professor Heneghan’s opinion might be relied upon.
When talking about the broad scope of evidence-based medicine Heneghan explains that “even my opinion” amounts to evidence, Baroness Hallett retorted dismissively:
“Not in my world it doesn’t, I’m afraid”.12
The Inquiry is now hopelessly compromised by the seemingly presumptive words of its own Chair and leading lawyers and its failure to ask the right questions.
It is setting us up for a doom-loop of catastrophic errors we cannot afford to repeat.
It has become an embarrassment to the legal profession and is jeopardising the reputation of the English legal system.
Its exorbitant costs already cannot be justified, and there is only worse to come. It should be abandoned.
https://principia-scientific.com/covid-inquiry-an-embarrassment-to-the-english-legal-system/
********************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Monday, October 30, 2023
Israeli Study: 0.62% of Healthcare Workers Jabbed with Pfizer’s mRNA Vax Show Biomarker for Myocarditis
A clinical trial (NCT05308680) in Israel was conducted by researchers at Shaare Zedek Medical Center to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.
Led by principal investigator Dr. Tal Hasin, Director of the Heart Failure Unit in the Cardiology Department at Shaare Zedek Medical Center, and colleagues, the team sought to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.
The findings of this study have been suppressed not discussed widely, although material. Why? 0.62% of adult healthcare workers evidenced biomarker signals for mild myocarditis. While this may not seem significant, it is. This represents an extraordinarily high percentage of cases, and importantly, the study did not focus on younger males, which are considered higher risk.
The principal investigators are very careful with their language but include subtle messaging to take very seriously. This includes the subtle insertion that the findings have “profound” implications for risk-benefit analyses concerning Pfizer’s mRNA vaccine.
Background
Registered in the American clinical trials registry, this study was based on population-based retrospective studies suggesting an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis.
The study authors point out the lack of large-scale studies to evaluate the incidence of myocarditis after the administration of the third or fourth vaccine doses, but case reports of myocarditis in recipients of the third dose were described. Although considered to be low, the estimated risk of myocarditis and myocardial injury in vaccine recipients is believed to be underestimated.
The Study
The Israeli investigators estimate the overall incidence of myocarditis at 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher.
In the present study, the team involved adult healthcare workers who received the BNT162b2 (Pfizer-BioNTech) vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign; the study participants’ blood samples were taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days.
Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and >50% increase from the first measurement.
Participants with evidence of myocardial injury underwent assessment for possible myocarditis, including electrocardiogram and echocardiography.
What did they find?
With results of this study recently reported in the European Journal of Heart Failure, Dr. Hasin and team reported that out of the study’s 324 participants, 192 (59.2%) were female, and the mean age was 51.8 ± 15.0 years.
Twenty-one (6.5%) participants had prior COVID-19 infection, the mean number of prior vaccine doses was 2.9 ± 0.4, and the median time from the last dose was 147 (142–157) days.
The study authors report, “Vaccine-related myocardial injury was demonstrated in two (0.62%) participants; one had mild symptoms, and one was asymptomatic; both had a normal electrocardiogram and echocardiography.”
In this prospective investigation, an increase in serum troponin levels was documented among 0.62% of healthy healthcare workers receiving the fourth dose BNT162b2 vaccine. The two cases had mild or no symptoms and no clinical sequela. Importantly, this represents a high overall percentage with implications for the hundreds of millions of persons vaccinated with the Pfizer vaccine.
For example, if these figures were extrapolated out to 100 million vaccinations, that would mean 617,284 cases involving an increase in serum troponin levels.
What do the study authors think of this output?
The authors do acknowledge a disturbing signal here, declaring: “Indeed, the current study suggests a higher incidence of myocardial injury during active monitoring for cardiac biomarkers in vaccine recipients with no clinical evidence of myocarditis. Since in our study, the average age was 51 and only 40% were male, with only 8 (2.47%) of them that were 30 years old or younger, it is currently unknown if a prospective evaluation among younger males will yield a higher incidence of myocardial injury.”
The study team further explains “Besides the pathophysiological implications, the clinical significance of the mild injury found in our study may be debated and should be further evaluated in larger studies.”
What’s the mechanism of action?
The mechanism of vaccine-induced myocarditis is unknown but may be related to the active component of the vaccine, the mRNA sequence that codes for the spike protein of SARS-CoV-2, or to an unregulated immune response that follows vaccination in certain individuals with a genetic predisposition.
The authors suggest that in some cases, acute myocardial injury may occur via a similar mechanism without material clinical myocarditis. They write, “Otherwise, a non-immune-mediated initial injury may trigger more significant immune-mediated myocarditis in susceptible individuals, but not in others.”
What are the recommendations given the findings?
Dr. Hasin and colleagues point out that given the potential magnitude of the findings (yet they downplay some more severe implications), they articulate, “A reasonable recommendation may be to withhold strenuous physical activity for a few months. Regarding the recommendation for repeat vaccine doses in the future, there is no consensus. However, given the limited clinical utility reported recently with the fourth dose against Omicron, repeat vaccination of individuals with documented post-vaccine myocardial injury deserves a profound risk–benefit consideration.”
Note, the use of the language—“profound” risk-benefit consideration moving forward!
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COVID Hospitalizations Continue to Drop, CDC Data Show
Hospitalizations for COVID-19 have continued to drop, coming after a relatively small increase in cases over the summer, according to data released by the U.S. Centers for Disease Control and Prevention (CDC).
Hospitalizations fell by 5 percent for the week ending Oct. 14, while emergency department visits also dropped by 11.9 percent, and reported case numbers decreased by 0.7 percent. Deaths rose by 4.2 percent, although officials say that deaths generally lag case and hospital numbers.
For the week ending on Oct. 7, hospitalizations were down by 8.2 percent, emergency visits fell 17.7 percent, and reported cases were down by 0.8 percent, while deaths fell 3.8 percent, the data show.
Amid the drop in hospitalizations over consecutive weeks, the CDC sent out a report earlier in October claiming the virus remains a "public health threat" for older Americans, arguing that it's a reason they should take the updated COVID-19 vaccine.
The Food and Drug Administration (FDA) and CDC both signed off last month on the updated shots made by Pfizer, Moderna, and Novavax.
Few Americans Taking Updated Shots
Around the same time, the CDC said officials are expecting a “moderate COVID-19 wave” for the winter months ahead and predicted this year's peak will match last winter’s hospitalization figures. The virus levels, however, could peak earlier this season because of "limited summer activity compared to past years,” the agency said in September.
“This increase could result from the emergence of a new COVID-19 variant with an increased ability to evade the body’s prior immunity, or from a severe influenza season combined with COVID-19 and RSV waves that are similar to last year, or, as we saw last year, an increase in RSV infections,” the CDC stated. “A key factor is the timing of the peak number of hospitalizations associated with each disease and whether those peaks coincide.”
About 3 percent of all Americans who are eligible have received the updated COVID-19 booster shot, nearly two months after it was rolled out, according to officials with the Department of Health and Human Services (HHS). Overall, about 10 million people have taken it, the data show, up from 7 million a week before.
“The administration remains committed to pulling every lever at its disposal during the fall respiratory vaccination campaign, encouraging the American public to stay up to date on their vaccines to keep themselves and their loved ones safe,” an HHS spokesperson told The Epoch Times earlier in October. “As a result of these efforts, around 10 million Americans have been vaccinated since the updated vaccines were authorized and recommended last month.”
The relatively lower pace of vaccinations prompted drug giant Pfizer to revise its revenue guidance for the year, warning that demand for COVID-19 products such as vaccines has plunged.
Pharma Profits Plunge
Pfizer, which has seen its stock drop by about 40 percent for 2023, slashed its outlook by about $9 billion due to the weakened demand, the company said on Oct. 13. It particularly expects sales of its mRNA vaccine to be about $2 billion lower than it previously anticipated.
As for Moderna, the company reiterated earlier this month that its COVID-19 vaccine sales will be between $6 billion and $8 billion. It’s still too early to predict the U.S. vaccination rate, Moderna said this month, coming as the company's stock plunged $7 billion in about a week and as its stock has dropped 83 percent since its peak in August 2021.
Some analysts said that the pharmaceutical companies should be worried about their vaccine sales.
“COVID-19 vaccine revenue concerns should be at an all-time high right now,” Hartaj Singh, an analyst at Oppenheimer, said in a recent Bloomberg report. “A good third-quarter print should allay some of these fears. And good guidance early next year on 2024 potential revenues could get the stock’s mojo back.”
It comes also as multiple U.S. hospitals in recent days have dropped their COVID-19 mask mandates after they reinstated the rule several weeks ago. A handful of hospitals across the United States reimplemented mandates over the summer, although some didn't make masks a requirement for patients or visitors, just staff such as nurses and doctors.
The largest hospital group in New Jersey, Hackensack Meridian Health, reinstated mask mandates last month. However, officials with the company have confirmed it has lifted its mandate for all its hospitals except for Bayshore Medical Center in Holmdel, Old Bridge Medical Center, and Southern Ocean Medical Center in Stafford, local media reported
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Sunday, October 29, 2023
Why COVID sufferers in the US can’t get ensitrelvir, the antiviral drug better than Paxlovid
For people suffering through a bout of COVID-19, the antiviral Paxlovid has been a godsend. The medication emerged as the go-to antiviral treatment during the pandemic after the Food and Drug Administration granted it emergency-use authorization in December 2021.
Now, there’s a new antiviral that’s superior to Paxlovid — but Americans can’t get it, as it’s being held up in the lengthy FDA-approval process.
Ensitrelvir, marketed as Xocova in Japan — the only country where it’s legally available — has several advantages over Paxlovid.
However, experts lament that the newer, better drug probably won’t be available in the US until the end of 2024. The FDA seems to be “slow walking” the approval process for ensitrelvir, infectious disease specialist Dr. David Boulware, a professor medicine at the University of Minnesota, told the Atlantic.
And because the COVID-19 emergency was declared over in May of this year, ensitrelvir probably won’t be granted the same emergency-use authorization that Paxlovid received.
Nonetheless, the FDA has granted the new drug “fast-track” status, meaning its review process will be expedited once the drug’s manufacturer, Shionogi of Osaka, Japan, submits the required documentation.
People who take the drug test negative almost two days sooner than people who take a placebo. Symptoms like fever, congestion, sore throat, cough and fatigue disappear faster among some groups of people than with Paxlovid.
“Rebound” infections, in which symptoms recede and then seem to come back — common among Paxlovid users — have been rare among users of ensitrelvir. In addiction, the taste of ensitrelvir is unremarkable, according to anecdotal reports, whereas patients on Paxlovid have described the aftertaste as “a mouthful of dirty pennies and rotten soy milk.”
And ensitrelvir is easier to take, as it requires just once-a-day dosing, whereas Paxlovid users must take three pills twice daily for five days.
The two drugs have never been compared in head-to-head trials, however, so medical experts are reserving their enthusiasm for ensitrelvir until more data is available.
Loss of smell and taste
Despite this, a new study found that ensitrelvir effectively diminishes one of the most annoying and problematic effects of a COVID infection: loss of smell and taste.
After seven days, the percentage of study participants with smell or taste loss was 39% lower in a group taking ensitrelvir than in a placebo group.
“Most people will eventually recover on their own, but we know that some people have had long-term issues with smell and taste,” Dr. Yohei Doi, an infectious-disease researcher at Fujita Health University in Japan who worked on the ensitrelvir study, told Nature.
“When the omicron variants became dominant, the loss of taste and smell started to become less and less common,” Dr. Amesh Adalja, an infectious-disease specialist at the Johns Hopkins Center for Health Security, explained to Nature.
“But it still occurs, and it is a distressing symptom,” Adalja added. “What we’re trying to do is not just minimize severe disease, hospitalization and death, but also to minimize the disruption that an infection has on people’s activities.”
The drugmaker Shionogi is continuing to conduct clinical trials into the safety and effectiveness of ensitrelvir among different user groups.
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Sore Arm After COVID-19 Vaccine Could Indicate Serious Complication: Doctor
Individuals who experience a sore arm after taking a COVID-19 shot may be at risk of facing cardiac issues, according to cardiologist Peter A. McCullough.
“I always ask patients if they had a sore arm or more severe reaction within the few days of the shot. It may be a harbinger of future cardiovascular serious adverse events, including myocarditis and sudden cardiac death,” Dr. McCullough said in an Oct. 27 Substack post. Myocarditis is an inflammation of a heart muscle called myocardium, which can reduce the heart’s ability to pump blood. Dr. McCullough cited a Sept. 19 study published in the Radiology journal, which states that 458 out of the 700 participants, or 65.4 percent, reported pain in the arm after COVID-19 vaccination.
“The myocardial visual score was higher in patients who reported a sore arm compared with those who did not,” the study said. The participants in the study were “competitive and recreational athletes” from Italy.
The cardiologist pointed to a July 20 study published by Taylor & Francis, which found this specific pain among the majority of participants who took COVID-19 vaccination.
Among the 460 participants in the study, 81.3 percent reported arm pain at the injection site after receiving the first dose of a COVID-19 shot. Following the second dose, 24.9 percent reported arm pain. “Male gender was more likely to present arm pain after the first and the second vaccinations,” it said.
“In our study population, arm pain was inversely associated with SARS-CoV-2 infection before vaccination.” Athletes who were previously infected with COVID-19 were found to be “less likely to present arm pain after the first-dose vaccination.”
CDC Advisers Consider Recommending Mpox Vaccines for Children
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A November 2022 study cited by Dr. McCullough looked at autopsy data from 25 individuals who had “died unexpectedly” within 20 days after COVID-19 vaccination.
Five individuals in the study received mRNA COVID-19 vaccines and died within a week of taking the shots. Four people died after the first injection, while the fifth died after the second dose.
In 80 percent of mRNA vaccine recipients, the study identified “acute (epi-)myocarditis without detection of another significant disease or health constellation that may have caused an unexpected death.”
The researchers discovered simultaneous vaccine-induced inflammation in the heart muscles and deltoid muscles crowning the shoulder. In the heart, the inflammation was found in the epicardium—the outermost protective layer of the organ located above the myocardium.
Dr. McCullough also highlighted a December 2022 report published at the National Library of Medicine, which brought attention to the issue of rising cardiac arrests among athletes.
During a two-year period “from January 2021 to the time of writing, 1,598 athletes suffered cardiac arrest, 1,101 of which with deadly outcome,” it said, citing a study.
This is a higher rate of death compared to a 38‐year timespan between 1966 and 2004 when “1,101 athletes under the age of 35 died (~29/years) due to various heart‐related conditions.”
Citing another study on 301 teenagers between the ages of 13 and 18 who received two doses of the Pfizer vaccine, the report said “29.24 percent of participants experienced cardiovascular complications such [as] tachycardia, palpitations, and 2.33 percent suffered myopericarditis.”
“It is noteworthy that no statistically significant increase in the incidence of myocarditis or pericarditis was observed in un‐vaccinated subjects after SARS‐CoV‐2 infection, in a large population study.”
On the basis of these studies, Dr. McCullough determined that a sore arm can be a “harbinger of future cardiovascular serious adverse events.”
The cardiologist said that he was “amazed at how many people have taken one or more of the COVID-19 vaccines are completely free of side effects.” He suggested that many of the vials of the vaccine may have had “little or no viable mRNA.”
A study from Germany published in the British Journal of Pharmacology journal this month found that both Pfizer and Moderna’s mRNA COVID-19 vaccines formed spike proteins in the human heart cells within 48 hours of injection. Both Pfizer and Moderna triggered different cell abnormalities.
Responding to the study, Dr. McCullough suggested that the different responses the cells had to the two mRNA vaccines could point to an mRNA toxicity reaction in these cells.
Despite studies suggesting the risk of medical complications, some experts continue to advise people to get COVID-19 jabs. According to John Hopkins Medicine, both Pfizer and Moderna are “highly effective in preventing serious disease, hospitalization, and death from COVID-19.”
It recommended people to get a COVID-19 shot as “we believe that their benefits outweigh their risks.”
However, Dr. McCullough advises people to avoid it. He wrote in an Oct. 29 Substack post: “I am not recommending COVID-19 XBB.1.5 boosters, influenza, or respiratory syncytial virus vaccines for healthy adults or children. None of these vaccines are compelling and conditions are easily treatable.”
********************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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